After receiving several complaints form home hemodialysis patients about difficulty using the Nipro BioHole Needle with CAPICK Scab Remover, Home Dialyzors United sent a letter to the FDA, asking the agency to revoke its approval of the needle. The needle has been on the market since its approval in March 2010.
"We believe that this device is not 'substantially equivalent' to the predicate devices cited in the approval letter of March 17, 2010, and that the differences pose significant risks to the health and safety of patients receiving dialysis for End-Stage Renal Disease (ESRD). We are requesting full review of the safety of this device," Home Dialyzors United said in the letter.
Home Dialyzors United (HDU), an advocacy and support group devoted to home dialysis patients, told NN&I that they had received complaints via two closed Facebook groups for HDU and Home Dialysis Central. At Nipro's request, HDU also solicited anonymous comments from group members, and submitted them to the company.
Concerns about needle design
HDU highlighted specific concerns regarding the safety of the needle, and allowed NN&I to view some of the anonymous patient comments. Nipro has responded to HDU's concerns in a letter. The specific concerns, and Nipro's responses, are included below.
Length of needle
In their letter, HDU said the Nipro needle is a ¼ inch longer than most predicate devices. This added length, HDU said, makes it easier for patients to puncture their fistula. Some patients have reported punctures and subsequent infections, and some said they had to use extreme caution because the "extra ¼ inch ends up against the back wall of the fistula."
Nipro response: The BioHole Needle has an exposed needle length of 1” or 1 ¼” as indicated on the device label and meets all Kidney Disease Outcomes Quality Initiative (KDOQI) and Fistula- first guidelines. The depth of cannulation is dependent on the cannulator and the patient’s access as written per clinic protocol as well as how the tunnel track was physically developed. This process is defined by national standards, not device manufacturers.
HDU and many patients also expressed concern about infection risk, because the CAPICK scab remover, which resembles the removable cap of a ballpoint pen, is included in the same package as the needle, rather than being packaged separately. "This means that as soon as the package for the needle is opened, the CAPICK can be exposed to non-sterile conditions, risking infection in the access site."
Nipro response: The CAPICK is an accessory to the BioHole Needle – packaged together for ease of use to the patient or clinician, just as the predicate device (Medisystems ButtonHole Needle with Steripick) is packaged. Packaging the CAPICK independently of the BioHole Needle would increase the manufacture cost, in turn increasing patient treatment costs as well as waste due to unnecessary packaging materials. The device would still be exposed to non-sterile conditions as soon as the package is opened, which is common for many medical devices, including the predicate. The device label advises not to use the device if the packaging is damaged (which would compromise the sterility), and the Instructions for Use (IFU) state to remove the CAPICK from the needle cap using aseptic technique. It is also stated in the IFU that a second skin disinfection is recommended, after the scab pick has been used, before cannulation.
Ease of use
HDU said "the tube is ½-inch shorter than other buttonhole needles. The scab picker is not shaped to remove the scab easily and completely for access to the fistula, and may, in fact, push pieces of the scab back into the fistula." Most of the patient complaints sent to NN&I involved the inability to pick the buttonhole scab with the CAPICK.
Nipro response: The BioHole Needle tubing is 12″ long, as indicated on the device label. The CAPICK was designed as a dull plastic needle with large finger grips to prevent the skin from being cut during use and with a bevel on each side of its point. It is for skin contact only and not to be used inside the tunnel track.
Air embolism risk
Many patients expressed concern about the frosted needle, which they say makes it hard to ensure the line is bubble free. "The NIPRO needles with CAPICK are frosted, rather than clear, making it more difficult to determine if the line has been adequately cleared of bubbles before use," HDU said.
Nipro response: The risk of micro air bubbles has many factors including needle entry angle cannulation and depth of the patients tunnel track. An AVF needle with a back-eye can also contribute to the micro air condition. These elements are independent of the tubing materials and coloring. The clarity of the needle tubing is comparable to the predicate tubing, which is also slightly frosted in color.
"We believe our device has proven substantial equivalence to the predicate device." Nipro said in the letter. "The issues that you have outlined in your letter can be significantly reduced with training provided by the Nipro Clinical team through the Nipro Connect Educational Program." -by Rebecca Zumoff